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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) The University of Texas Health Science Center, Houston |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00218569 |
The purpose of this study is to examine whether Naltrexone and cognitive behavioral therapy can be helpful in patients who want to stop using cocaine and alcohol.
Condition | Intervention | Phase |
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Alcohol Dependence Cocaine Dependence |
Drug: Naltrexone Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Combined Treatment for Cocaine-Alcohol Dependence |
Enrollment: | 87 |
Study Start Date: | April 2003 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Naltrexone
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Drug: Naltrexone
Naltrexone
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2: Experimental
Placebo
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Drug: Placebo
Placebo
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This is a randomized, double blind placebo-controlled trial to examine the role of Relapse Prevention (RP) and Contingency Management (CMP) combined with Naltrexone (NTX) for the treatment of cocaine-alcohol dependence. Patients will be randomly assigned to NTX (100mg/d) or placebo combined with one of two psychotherapy conditions (RP or RP +CMP). Following a standardized consent and intake procedure patients will participate in a 12-week trial with thrice weekly visits. Manual-guided RP therapy will be delivered in weekly 60-minute individual sessions. CMP will be based on cocaine-negative urine screens and negative breath alcohol tests. Follow-up assessments will be conducted at 3 and 6 months after treatment.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
University of Texas Health Sci Cntr Houston | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Joy Schmitz, Ph.D. | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas Medical School at Houston ( Joy M. Schmitz, Ph.D. ) |
Study ID Numbers: | NIDA-15801-1, R01-15801-1 |
Study First Received: | September 20, 2005 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00218569 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Alcohol Dependence Cocaine Dependence |
Cocaine-Related Disorders Dopamine Mental Disorders Naltrexone Alcoholism |
Substance-Related Disorders Disorders of Environmental Origin Alcohol-Related Disorders Cocaine Ethanol |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Narcotic Antagonists Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Cardiovascular Agents |
Pharmacologic Actions Anesthetics, Local Sensory System Agents Therapeutic Uses Vasoconstrictor Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |